BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 20295722 · Received September 24, 2024

    Report

    Report Number
    3005778470-2024-00927
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Report Date
    September 12, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    UDI-DI
    30768455143529
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MDR / INITIAL 4 OF 5 BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 3005778470.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THIS COMPLAINT HAS BEEN EVALUATED AS TYPE 2 INVESTIGATION CASE. PHOTOS HAVE BEEN ATTACHED. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1718754 - GENTLECATH GLIDE MALE CH10 AND MANUFACTURING LOT#4A02567 IN JANUARY 2024 IN AMOUNT (B)(4) PIECES ON PACKAGING MACHINE P009. DURING LOT PRODUCTION WAS USED PAPER GAS COAT NRW GRID GLIDE MALE XRAY, SUPPLIER LOT OF/31358 SAP 1736865. PAPER IS SUPPLIED BY EXTERNAL SUPPLIER AMCOR. DURING INCOMING INSPECTION, THE CERTIFICATE ISSUED BY SUPPLIER IS INSPECTED AND THEN THE PAPER IS RELEASED TO PRODUCTION. NO DEVIATION WAS OBSERVED. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING, PACKAGING AND STERILIZATION PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION PROCESS OF THE MENTIONED LOT. NO SIMILAR COMPLAINT WAS RECEIVED TO THIS LOT AND ISSUE. ACCORDING TO G905704 V.27.0 WORK INSTRUCTION FOR PACKAGING OF GENTLECATH GLIDE CATHETERS ON P009/P006/P9020 WAS PROVIDED VISUAL INSPECTION OF PACKED CATHETERS BY OPERATOR. RESULTS WERE RECORDED TO G905704 V.27.0 FORM 3. ACCORDING TO THIS PROCESS INSTRUCTION POINT 5.11.1 BURST TEST IS PROVIDED IN COMPLIANT WITH G805066 AND RESULTS ARE RECORDED BY THE PACKING MACHINE OPERATOR. DURING PRODUCTION OF LOT#4A02567 ALL TEST HAVE BEEN CARRIED OUT, AND NO DISCREPANCIES WERE FOUND. THE PERCENTAGE OF AFFECTED PIECES AGAINST LOT IS (B)(4). THIS COMPLAINT WAS DISCUSSED ON COMPLAINT REVIEW BOARD ON OCTOBER 10, 2024. ATTENDEES DECIDED THAT NO FURTHER ACTION ARE REQUIRED. THIS IS CONSIDERED AN ISOLATED ISSUE. OPERATORS WILL BE RETRAINED ACCORDING TO G708002 EDUCATION AND TRAINING OF PRODUCTION PERSONNEL AND THE ISSUE WILL BE PRESENTED TO OPERATORS ACCORDING TO WI-001366 QA DATA VISUALIZATION. ATTENDEES DECIDED THAT NO FURTHER ACTIONS ARE NEEDED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, SOP-000741. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 3005778470.

    Description of Event or Problem · 0

    END USER REPORTS "PAPER HAS TORN AT THE BACKSIDE WHEN IT COMES TO BE ACTIVATED". THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091511 GENTLECATH GLIDE CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 421565 4A02567 30768455143529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown